Wednesday, February 10, 2010

PLx Pharma, a Houston area pharmaceutical company, is looking for an experienced medical writer who can assist in the preparation of reports and submissions to the FDA, related to:

- Reports of non-clinical studies. For example…

o Formulation studies in which materials are characterized via HPLC, FTIR, HPTLC, or other analytical methods;o Non-GMP stability studies;o Rodent studies evaluating safety and efficacy of test articles.- Regulatory submissions, particularly related to various Chemistry, Manufacturing, and Controls (CMC) items. For example,…o Integrated discussion of GMP stability programs for products in development, including synthesis of data;o Summary and discussion of manufacturing process development, from pilot scale to commercial scale (i.e., enumeration of changes over time and at various scales, with rationale);o Authoring various sections of the Quality (CMC) module of the Common Technical Document/New Drug Application for one or more products.

Our preference would be to identify one or more persons who are local, are experienced in producing reports for pharmaceutical/biotech companies, and have some familiarity with the various analytical methods mentioned. Although the writer need not be local, at least some direct experience is required. Expertise in pharmaceutics would be a plus.

This writing opportunity would be on a contract, part-time basis, but could occupy from 25% to 75% of a writer’s time, based on the projects that are ultimately assigned, availability, and rate.

Those wishing to be considered for this opportunity should email Jason Moore at jason.moore (AT) plxpharma.com, attaching a work summary or resume/CV.